Spencer CROSS, Руководство пользователя, Страница: 12 / 27

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To ensure the traceability of the products and protect maintenance and service procedures on your devices, Spencer has made the SPENCER
SERVICE portal (
http://service.spencer.it/ ) available to you. From this site, you can view the data of the products in your possession or placed
on the market, monitor and update schedules for periodic checks and view and manage special maintenance.
5. WARNINGS
Warnings, notes, and other important safety information are provided in this section and are clearly visible throughout the manual.
At least every 6 months, it is important to check for updated instructions and any changes involving your product. This information is freely
available on the website www.spencer.it on the specific product page.
Product features
Use of the product for any purpose other than that described in the User Manual is prohibited.
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Before each use, always check the conditions of the product, as specified in the User Manual. In the event of faults/damage that could
compromise its functionality/safety, immediately remove it from service and contact the Manufacturer.
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If the product is found to be malfunctioning, immediately use a similar device to ensure continuity of ongoing operations.
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The product must not be tampered with (modification, tweaking, additions, repair). Should these operations be performed, we decline
any responsibility for incorrect operation or any damage caused by the product itself; moreover, the CE certification (when required by
law) and the product warranty shall be null and void.
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Anyone who modifies or causes products manufactured by Spencer Italia S.r.l. to be modified or re-processed in such a way that they no
longer serve the intended purpose or no longer provide the intended performance shall comply with the conditions valid for the first
placing on the market.
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When using the devices, position and adjust them in such a way that they do not hinder operator works or the use of any other
equipment.
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Be sure to take every precaution to avoid hazards from contact with blood or body secretions, if applicable.
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Always comply with the maximum capacity indicated in the User Manual. Maximum load capacity means the total weight distributed
according to human anatomy. When determining the total weight load on the product, the operator should consider the weight of the
patient, equipment and accessories. In addition, the operator should assess whether the overall size of the patient reduces the
functionality of the product.
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Make sure that operators are in good physical condition before lifting, as listed in the User Manual.
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The maximum weight, which weighs on each operator, must comply with local health and safety requirements.
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Avoid contact with sharp objects.
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Device installation must be carried out by qualified personnel trained and enabled by Spencer Italia S.r.l. The times and methods of such
shall be agreed upon between the customer and our Sales Offices.
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Operating temperature: from -10°C to + 50°C.
Storage
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The product must not be exposed or come into contact with thermal sources of combustion or flammable agents, but must instead be
stored in a dry, cool place, away from light and sun.
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Do not store the product under other more or less heavy materials that may damage the structure of the product.
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Store and transport the product with its original packaging, otherwise the warranty shall be invalidated.
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Storage temperature: -20°C to +60°C.
Regulatory requirements:
As Distributor or End-User of the products manufactured and/or marketed by Spencer Italia S.r.l., users are strictly required to be familiar
with the legal provisions in force in the country of destination of the goods, applicable to the devices to be supplied (including regulations
relating to technical specifications and/or safety requirements) and, therefore, to understand the requirements necessary to ensure
compliance of the products themselves with all legal requirements of the territory.
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Promptly and in detail notify Spencer Italia S.r.l. (already in the quotation request phase) about possible fulfilments by the Manufacturer
necessary for the compliance of products with specific legal requirements of the territory (including those deriving from regulations
and/or regulatory provisions of another nature).
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Act with due care and diligence to help ensure compliance with the general safety requirements of the devices placed on the market,
providing end-users with all the information necessary to carry out periodic revisions on the supplied devices, exactly as indicated in the
User Manual.
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Participate in safety checks on products placed on the market, transmitting information regarding product risks to the Manufacturer as
well as to the Competent Authorities for their respective actions.
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Without prejudice to the above, the Distributor or End-User shall assume wider liability related to non-compliance with non-fulfilment of
the above-mentioned obligations, with consequent obligation to indemnify and/or hold Spencer Italia S.r.l. harmless from any possible
injurious effect.
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With reference to EU Regulation 2017/745, please note that public or private operators who, when exercising their activity, detect an
incident involving a medical product are required to notify the Ministry of Health, within the terms and in the manner established by one or
more ministerial decrees, and notify the Manufacturer. Public or private health care professionals are required to notify the Manufacturer of
any other incident that may allow the adoption of measures to ensure the protection and health of patients and users.